Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Giant Cell Arteritis
About this trial
This is an interventional treatment trial for Giant Cell Arteritis
Eligibility Criteria
Inclusion criteria :
- Diagnosis of GCA according to European League Against Rheumatism/American College of Rheumatology classification criteria.
- New onset active disease or refractory active disease.
- At least one of the symptoms of GCA within 6 weeks of baseline.
- Either erythrocyte sedimentation rate greater than or equal to (>=) 30 millimeter per hour or C-reactive protein >=10 mg per liter within 6 weeks of baseline.
- Received or were able to receive prednisone 20-60 mg/day for the treatment of active GCA.
Exclusion criteria:
- Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).
- Major ischemic event, unrelated to GCA, within 12 weeks of screening.
- Any prior use of the following therapies, for the treatment of GCA:
- Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
- Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.
- Abatacept within 8 weeks of baseline.
- Anakinra within 1 week of baseline.
- Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half-lives had elapsed prior to baseline, whichever was longer.
- Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological Interleukin 6 (IL-6) IL-6/(R) antagonist (prior experience with IL-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline was not exclusionary).
- Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
- Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine, mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and had been stable for at least 3 months prior to baseline was not exclusionary).
- Concurrent use of systemic CS for conditions other than GCA.
- Use of intervascular CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.
- Pregnant or breastfeeding woman.
- Participants with active or untreated latent tuberculosis.
- Participants with history of invasive opportunistic infections.
- Participants with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
- Participants with uncontrolled diabetes mellitus.
- Participants with non-healed or healing skin ulcers.
- Participants who received any live, attenuated vaccine within 3 months of baseline.
- Participants who are positive for hepatitis B, hepatitis C and/or HIV.
- Participants with a history of active or recurrent herpes zoster.
- Participants with a history of or prior articular or prosthetic joint infection.
- Prior or current history of malignancy.
- Participants who have had surgery within 4 weeks of screening or planned surgery during study.
- Participants with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation..
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 8400002
- Investigational Site Number 8400017
- Investigational Site Number 8400014
- Investigational Site Number 8400018
- Investigational Site Number 8400019
- Investigational Site Number 8400011
- Investigational Site Number 0320001
- Investigational Site Number 0320002
- Investigational Site Number 0360003
- Investigational Site Number 0360006
- Investigational Site Number 0360001
- Investigational Site Number 0560001
- Investigational Site Number 1240007
- Investigational Site Number 1240010
- Investigational Site Number 1240001
- Investigational Site Number 1240005
- Investigational Site Number 1240003
- Investigational Site Number 1910001
- Investigational Site Number 2080002
- Investigational Site Number 2080003
- Investigational Site Number 2330001
- Investigational Site Number 2500005
- Investigational Site Number 2500002
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- Investigational Site Number 2500001
- Investigational Site Number 2500006
- Investigational Site Number 2760001
- Investigational Site Number 2760002
- Investigational Site Number 2760003
- Investigational Site Number 2760004
- Investigational Site Number 2760007
- Investigational Site Number 3480001
- Investigational Site Number 3760006
- Investigational Site Number 3760004
- Investigational Site Number 3800001
- Investigational Site Number 3800005
- Investigational Site Number 5280007
- Investigational Site Number 5280005
- Investigational Site Number 5280009
- Investigational Site Number 5280001
- Investigational Site Number 6200001
- Investigational Site Number 6200005
- Investigational Site Number 6200004
- Investigational Site Number 6430005
- Investigational Site Number 6430002
- Investigational Site Number 6430003
- Investigational Site Number 7050001
- Investigational Site Number 7240010
- Investigational Site Number 7240011
- Investigational Site Number 7240014
- Investigational Site Number 7240016
- Investigational Site Number 7240015
- Investigational Site Number 7520001
- Investigational Site Number 7520003
- Investigational Site Number 7560002
- Investigational Site Number 8260006
- Investigational Site Number 8260004
- Investigational Site Number 8260003
- Investigational Site Number 8260005
- Investigational Site Number 8260011
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo+52 Week Taper
Placebo+26 Week Taper
Sarilumab 150mg q2w+26 Week Taper
Sarilumab 200mg q2w+26 Week Taper
Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Participants received sarilumab 150 milligrams (mg) as SC injection q2w up to 52 weeks along with prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.